Spanish Urological Association Registry of Patients on Active Surveillance

February 9, 2018 updated by: Fundación Instituto Valenciano de Oncología

Description:

Multicentre observational study, not randomized. Ambispective character (retro and prospective). Opened to any member of the Asociación Española de Urología (AEU), public and private medicine.

Justification:

Active surveillance is a strategy proposed to control the overtreatment derived from the opportunist screening in prostate cancer (PCa).

Its development in our country is erratic and different in every Center. This database tries to include most of patients included in active surveillance in Spain with a few minimal inclusion criteria.

Multicentre registry and follow up of the active surveillance in Spain.

Hypothesis:

Mortality cancer specific for PCa includible in active surveillance to 15 years is lower than 5 %.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

946

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncología
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Spain male residents diagnosed with low risk PCa (NCCN)

Description

Inclusion Criteria:

  1. PSA ≤ 10 ng / mL; if prostate volume> 60 cc in transrectal, ultrasound includable with PSA>10 ng / ml if PSAD <0.20
  2. Local Stadium DRE; cT1c -cT2a
  3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders
  4. Adenocarcinoma Prostate Gleason ≤ 6 (3 + 3) with local and central pathology review
  5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment
  6. <80 years and greater expectancy to 10 years life (Charlson score)
  7. Patients able to understand active surveillance and sign the Informed Consent

Exclusion Criteria:

  1. Patient not be able to accept up with repeat biopsies
  2. Patient who does not want to sign the Informed Consent
  3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria
  4. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)
  5. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avidart®) and finasteride (Proscar®) during the previous six months
  6. Patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. It can be associated with an increase of PSA prior to phlebotomy. These therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer specific survival in patients in active surveillance
Time Frame: up to 15 years

Global CSS will be recorded, independently of each Center protocol, from enrollment to death due to PRostate Cancer Estimated CSS will be analyzed at 5, 10 and 15 years from initiation of the protocol.

To this purpose, patients will be followed although they progressed and went into active treatment.
up to 15 years
Overall survival
Time Frame: Date randomization-date death, or up to 15 years, whichever came first
Global OS will be recorded, independently of each Center protocol, from enrollment to death of any cause Estimated OS will be analyzed at 5, 10 and 15 years from initiation of the protocol To this purpose, patients will be followed although they progressed and went into active treatment or if the kept in active surveillance till their death due to any cause.
Date randomization-date death, or up to 15 years, whichever came first
Active treatment-free interval
Time Frame: Date start active surveillance-stop active surveillance due to active treatment, or up to 15 years, whichever came first
Time to active treatment will be recorded, independently of each Center protocol, from enrollment to any other active due to prostate cancer progression or patient desire to receive any active treatment Estimated active treatment free survival will be analyzed at 2, 5 and 10 years from initiation of the protocol.
Date start active surveillance-stop active surveillance due to active treatment, or up to 15 years, whichever came first
Characterization of pathologically agressive tumors by Gleason score
Time Frame: From the study start and stop until 15 years
Characterization of pathologically agressive tumours will be done by analyzing the pathological reports of radical prostatectomy specimens derived from patients included in the protocol that went on to radical prostatectomy. This has no time frame, although time of radical prostatectomy will be a variable to take in account for comparisions among different timings of performace of radical prostatectomies.
From the study start and stop until 15 years
Characterization of pathologically agressive tumors by TNM
Time Frame: From the study start and stop until 15 years
Characterization of pathologically agressive tumours will be done by analyzing the pathological reports of radical prostatectomy specimens derived from patients included in the protocol that went on to radical prostatectomy. This has no time frame, although time of radical prostatectomy will be a variable to take in account for comparisions among different timings of performace of radical prostatectomies.
From the study start and stop until 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in patients with active surveillance
Time Frame: up to 5 years
Assessed with CAVIPRESS-30 questionaires
up to 5 years
Quality of Life in patients with active surveillance
Time Frame: up to 5 years
Assessed with EPIC-20 questionaires
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Instituto Valenciano de Oncología

Investigators

  • Principal Investigator: Jose Rubio Briones, MD, PhD, IVO
  • Principal Investigator: Ángel Borque Fernando, MD, PhD, Hospital Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

July 1, 2034

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEU-PIEM/2014/0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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